Economic Analysis of RSVpreF

Maternal Vaccination

David W. Hutton, PhD, MS

Professor, Health Management and Policy, School of Public Health

Professor of Global Public Health, School of Public Health

Professor, Industrial and Operations Engineering, College of Engineering

University of Michigan

September 22, 2023
Research team

University of Michigan

• David Hutton, PhD

• Lisa Prosser, PhD

• Angela Rose, MPH

• Kerra Mercon, MS

CDC

• Jefferson Jones, MD, MPH, FAAP

• Mila Prill, MSPH

• Meredith McMorrow, MD, MPH, FAAP

• Jamison Pike, PhD

• Katherine Fleming-Dutra, MD, FAAP

• Ismael Ortega-Sanchez, PhD

• Fiona Havers, MD

• Betsy Gunnels, MSPH

• Andrew Leidner, PhD

2
Conflicts of interest statements

• Authors have no known conflict of interests.

3
• Additional vaccine efficacy scenario

• Additional timing scenarios

• Months of year to administer

• 32 Τ

0

7 - 36 Τ

6

7 weeks gestation

• Updated cost/dose

Updates Since June 21 Presentation

Economic Analysis of RSV Vaccination in Older Adults, June 21, 2023
0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

Against medically-attended RSV-associated LRTI Against hospitalization

5

Methods: RSVpreF efficacy

average 6-month efficacy = efficacy against 

hospitalization or medically-attended RSVassociated LRTI

Zero efficacy

Source: Kampmann et al 2023

LRTI= Lower respiratory tract infection
0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

Against medically-attended RSV-associated LRTI Against hospitalization

6

Methods: RSVpreF efficacy

alternate flat scenario

Zero efficacy

Source: Kampmann et al 2023

LRTI= Lower respiratory tract infection

average 6-month efficacy = efficacy against 

hospitalization or medically-attended RSVassociated LRTI
0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

severe MA RSV LRTI MA RSV LRTI

7

Methods: RSVpreF efficacy

Optimistic scenario: Severe Efficacy with VE to 9 months

6-month efficacy against 

Severe MA RSV LRTI

Zero efficacy 

at 9 months

6-month efficacy against 

MA RSV LRTI

MA: Medically-attended, LRTI: Lower Respiratory Tract Infection
Methods: Provision of RSVpreF

8

• Base case:

• Year round

• Scenarios

• Individual Months

• Ranges of Months

• April-February

• May-February

• June-February

• August-January

• September-January

• September-December
• Mother vaccinated 

• During 32 Τ

0

7 - 36 Τ

6

7 weeks gestation, evenly distributed

• Birth 

• Must be >2 weeks after vaccination for protective efficacy to pass to infant, 

based on historical gestational age

9

Methods: Provision of RSVpreF
Methods: Provision of RSVpreF

10

In Time= >2 weeks prior to delivery

100 Pregnant persons 50 

No intention

50 

Intend to Vaccinate

45 

Vaccinated

in time

2 

Birth before vaccination Uptake

Timing

48

Vaccinated

3 

Vaccinated < 2 weeks 

before delivery
Results: Base case

11

• Base case:

• Population of annual US births (3.66 million)

• 50% intended uptake in the RSVpreF group

• First RSV season

• $295/dose

• RSVpreF only impacts lower respiratory tract infections
Results: Number Needed to Vaccinate

12

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group

40 

115 

242 

1,100 

45 

367 

 -

 200

 400

 600

 800

 1,000

 1,200

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Number needed to Vaccinate to avoid

RSVPreF
Results: Costs

13 Base costs of RSVpreF: $295/dose, both natural history and RSVPreF involve palivizumab for high-risk children

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group

$0

$500

$1,000

$1,500

$2,000

$2,500

Natural

History

RSVPreF Natural

History

RSVPreF Natural

History

RSVPreF Natural

History

RSVPreF Natural

History

RSVPreF Natural

History

RSVPreF

Intervention Outpatient ED Inpatient Deaths Total

Total Costs in Cohort

Millions

Medical Productivity
Results: Cost per Event Averted

14 Base costs of RSVpreF: $295/dose

$11,337 

$32,652 

$68,423 

$311,013 

$12,671 

$103,671 

 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Cost per Event Averted

RSVPreF
Results: Cost-Effectiveness

15

Base costs of RSVpreF: $295/dose

QALY= quality-adjusted life-year; ICER= incremental cost-effectiveness ratio

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group, ICER is not affected by uptake

Overall Costs ($) QALYs lost ICER ($/QALY)Vs. NH

Natural History 1,585,172,002 18,151 

RSVpreF 2,103,215,047 16,857 400,304 
$0 $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000

Probability of Prematurity

RSV QALYS Lost

RSVpreF vaccine cost/dose

Disease-specific inpatient costs (per inpatient case)

Vaccination Efficacy, Hospitalized RSV LRTI through 180 days

Vaccination Efficacy, RSV MA-LRTI through 180 days

Proportion of RSV infections with an LRTI diagnosis Outpatient Age 0-5 months

Proportion of RSV infections with an LRTI diagnosis ED Visits Age 0-5 months

Proportion of RSV infections with an LRTI diagnosis Hospitalizations Age 0-5 months

RSV mortality per hospitalization Age 0-5 months

Incremental Cost-Effectiveness Ratio

Low High

Sensitivity: Tornado RSVpreF

16

Base cost of RSVpreF: $295/dose

MA= Medically-attended

LRTI= Lower respiratory tract infection

QALY= Quality adjusted life year

$1.3 million
Methods: RSVpreF efficacy

“flat efficacy” scenario

17

Overall Costs ($) QALYs lost ICER ($/QALY)

Natural History 1,585,172,002 18,151 

RSVpreF 2,094,993,469 16,757 365,669 

Slightly lower costs with 

RSVpreF, slightly fewer 

QALYs lost, slightly lower 

ICER

ICER: Incremental cost-effectiveness ratio

LRTI= Lower respiratory tract infection
Sensitivity Analysis: More Optimistic Efficacy

18

Base costs of RSVpreF: $295/dose

QALY= quality-adjusted life-year; ICER= incremental cost-effectiveness ratio

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group, ICER is not affected by uptake

Overall Costs ($) QALYs lost ICER ($/QALY)Vs. NH

Natural History 1,585,172,002 18,151 

RSVpreF 2,056,423,553 16,504 286,179 

Higher and longer efficacy

MA: Medically-attended, LRTI: Lower Respiratory Tract Infection
19

Sensitivity: Varying Efficacy, Hospitalization Cost, and 

Mortality

Base

$0

$100,000

$200,000

$300,000

$400,000

$500,000

$0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000

ICER

Hospitalization Cost

0.1% Mortality, Base Efficacy 0.1% Mortality, Optimistic Efficacy

1.0% Mortality, Base Efficacy 1.0% Mortality, Optimistic Efficacy
 $-

 $100,000

 $200,000

 $300,000

 $400,000

 $500,000

 $600,000

 $700,000

 $800,000

$0 $50 $100 $150 $200 $250 $300 $350 $400 $450 $500

ICER

Cost per dose of RSVpreF

Sensitivity: Cost RSVpreF

20

Base Case
Results: RSVpreF timing scenarios

21

• Scenarios

• Base: vaccine given year-round

• By Month

• During April-February

• During May-February

• During June-February

• During August-January

• During September-January

• During September-December
Results: RSVpreF timing scenarios

$351,238 $333,255 

$181,649 

$115,445 $111,248 

$174,344 

 $-

 $100,000

 $200,000

 $300,000

 $400,000

 $500,000

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

ICER ($.QALY)

ICER: RSVpreF vs. Natural History

Month of administration 22
Results: RSVpreF timing scenarios

$400,304 

$363,344 

$322,594 

$282,498 

$186,256 $167,280 $141,806 

 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

 $400,000

 $450,000

Base Apr-Feb May-Feb Jun-Feb Aug-Jan Sep-Jan Sep-Dec

ICER ($.QALY)

ICER: RSVpreF vs. Natural History

23
Limitations

• Model Structure

• No risk groups

• No dynamic transmission. No impact of the vaccine on transmission and 

indirect effects

• Uncertain inputs

• RSVpreF cost 

• QALYs lost 

• Upper respiratory tract infections

• Prematurity

• Assumption: no infants will be receiving nirsevimab

24
Summary

• RSVpreF may improve RSV outcomes, but will also increase costs

• RSVpreF has the potential to be cost-effective

• Results sensitive to:

• Rate of prematurity 

• Cost per dose (~65,000 –68$/QALY)

• Hospitalization Costs (Cost-saving – 440,000 $/QALY)

• Efficacy (~280,000 – 680,000 $/QALY)

• QALYs lost (~100,000 – 800,000 $/QALY)

• Month of Administration (~110,000 – Millions $/QALY)

25

QALY: Quality-Adjusted Life-Year
Economics of combined use of Pfizer 

maternal RSVpreF vaccine and 

nirsevimab

David W. Hutton, PhD, MS

Professor, Health Management and Policy, School of Public Health

Professor of Global Public Health, School of Public Health

Professor, Industrial and Operations Engineering, College of Engineering

University of Michigan

September 22, 2023
• On August 3, 2023, the Advisory Committee on Immunization 

Practices (ACIP) recommended use of nirsevimab

• How should we think about combinations of RSVpreF and 

nirsevimab?

• If we know RSVpreF has been administered in time, how cost-effective is it to 

provide nirsevimab?

• If we know the infant will receive nirsevimab, how cost-effective is it to 

provide RSVpreF?

Methods: Study questions
• RSVpreF will be administered in weeks 32-36

• Because of this, we are assuming the infant is full-term, and therefore, there is no need for 

palivizumab for any newborns considered in this analysis

• Consideration of higher-risk populations (but assuming they are not premature)

• New timing of RSVpreF administration

Updates since June
Methods: Intervention effectiveness

• NO evidence of efficacy on the combined use of these products

• Assumption:

• Efficacy equal to the highest of nirsevimab or RSVpreF:

• Efficacy would not be higher than from the most effective product

29
0%

20%

40%

60%

80%

100%

0 2 4 6 8 10 12 14

Hospitalization Efficacy

Months since birth

RSVPreF Both Nirsevimab

Methods: Intervention effectiveness

30

Additional benefit of adding nirsevimab

* Assuming administration of nirsevimab at birth
0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 2 4 6 8 10 12

Hospitalization Efficacy

Month

Both RSVpreF Only

Methods: Intervention effectiveness

Example: Off-peak (Aug) birth

Additional benefit of adding nirsevimab

Note: Peak infections are typically Dec-Feb 31
Incremental benefit of adding nirsevimab on top of 

RSVpreF

32

• For infants of persons vaccinated with RSVpreF during pregnancy at 

least 2 weeks prior to delivery
Results: Incremental benefit of adding nirsevimab

on top of RSVpreF: Higher Risk

• Higher-Risk

• Increased multiplier on 

• risk of hospitalization 

• No change in

• Outpatient incidence

• ED incidence

• Cost/outcome

• QALYs/outcome

33
Results: Incremental benefit of adding nirsevimab

on top of RSVpreF: By Month and Risk

 $-

 $200,000

 $400,000

 $600,000

 $800,000

 $1,000,000

 $1,200,000

 $1,400,000

 $1,600,000

 $1,800,000

ICER

1x 2x 3x 6x 10x

34

Nirsevimab given in Oct-Mar

ICER= Incremental cost effectiveness ratio ($/QALY)

If the 10x bars are “missing”, providing nirsevimab is cost-saving.

Birth Month

Risk Level

Nirsevimab given at birth Nirsevimab given Oct/Nov
Results: Incremental benefit of adding nirsevimab

on top of RSVpreF: By Month and Risk

 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

ICER

3x 6x 10x

35

Nirsevimab given in Oct-Mar

ICER= Incremental cost effectiveness ratio ($/QALY)

If the 10x bars are “missing”, providing nirsevimab is cost-saving.

Birth Month

Risk Level

Nirsevimab given at birth Nirsevimab given Oct/Nov
Results: Adding nirsevimab to all infants born yearround to vaccinated mothers

 -

 200

 400

 600

 800

 1,000

 1,200

 1,400

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Number Needed to Immunize to 

Avoid One...

1x 2x 3x 6x 10x

36

Nirsevimab given at birth for babies born October-March, and in October/November for babies born in April through 

September to mothers who received RSVpreF at least 2 weeks prior to delivery
Results: Adding nirsevimab to all infants born yearround to vaccinated mothers

37

Notes: Nirsevimab given at birth for babies born October-March, and in October/November for babies born in April through September to 

mothers who received RSVpreF at least 2 weeks prior to delivery

ICER= Incremental cost effectiveness ratio; QALY= Quality-adjusted life-year

$413,035 

$282,083 

$192,782 

$40,256 

 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

 $400,000

 $450,000

ICER

ICER

1x 2x 3x 6x 10x

Cost-Saving
Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF at least 2 weeks prior to delivery

Results: Adding nirsevimab at the start of the 

season only for infants born Apr-Sept

 -

 200

 400

 600

 800

 1,000

 1,200

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Number Needed to Immunize to 

Avoid One...

1x 2x 3x 6x 10x

38
Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF at least 2 weeks prior to delivery

ICER= Incremental cost effectiveness ratio; QALY= Quality-adjusted life-year

Results: Adding nirsevimab at the start of the 

season only for infants born Apr-Sept

39

$305,182 

$203,194 

$131,505 

$4,830 

 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

ICER

1x 2x 3x 6x 10x

Cost-Saving
Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF at least 2 weeks prior to delivery

Results: Adding nirsevimab during the season for 

infants born Oct-Mar

 -

 200

 400

 600

 800

 1,000

 1,200

 1,400

 1,600

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Number Needed to Immunize to 

Avoid One...

1x 2x 3x 6x 10x

40
Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF at least 2 weeks prior to delivery

ICER= Incremental cost effectiveness ratio; QALY= Quality-adjusted life-year

Results: Adding nirsevimab during the season for 

infants born Oct-Mar

41

$606,362 

$416,695 

$293,926 

$95,537 

 $-

 $100,000

 $200,000

 $300,000

 $400,000

 $500,000

 $600,000

 $700,000

ICER

1x 2x 3x 6x 10x

Cost-Saving
• Additional benefit beyond RSVpreF protection

• ICERs are high, but could be lower for higher-risk populations, 

particularly if born off-peak

Summary: Incremental benefit of 

adding nirsevimab on top of RSVpreF

42
Incremental benefit of adding RSVpreF on top of 

nirsevimab

• If you know the infant will be receiving nirsevimab

43
Results: Incremental benefit of adding RSVpreF on 

top of nirsevimab

$2.4 

$6.0 

$9.4 

$5.0 

$3.6 

 $-

 $1.0

 $2.0

 $3.0

 $4.0

 $5.0

 $6.0

 $7.0

 $8.0

 $9.0

 $10.0

ICER (Millions)

44

Birth Month

ICER= Incremental cost effectiveness ratio
Summary: Incremental benefit of adding RSVpreF

on top of nirsevimab

• Very marginal additional benefit beyond nirsevimab protection

• ICERs are extremely high

45
Overall summary: Combinations

• Limitation:

• No efficacy data for combination of products

• Nirsevimab may add additional protection on top of RSVpreF, 

particularly for higher-risk infants.

• Adding RSVpreF on top of nirsevimab adds marginal effectiveness at 

very high cost in the general population

46
Thank You

• Please send comments to:

• dwhutton@umich.edu

47
Appendix to Economics of Pfizer maternal 

RSVpreF vaccine

48
Research team

University of Michigan

• David Hutton, PhD

• Lisa Prosser, PhD

• Angela Rose, MPH

• Kerra Mercon, MS

CDC

• Jefferson Jones, MD, MPH, FAAP

• Mila Prill, MSPH

• Meredith McMorrow, MD, MPH, FAAP

• Jamison Pike, PhD

• Katherine Fleming-Dutra, MD, FAAP

• Ismael Ortega-Sanchez, PhD

• Fiona Havers, MD

• Betsy Gunnels, MSPH

• Andrew Leidner, PhD

49
Conflicts of interest statements

• Authors have no known conflict of interests.

50
Methods: Study question

• Determine the cost-effectiveness of RSVpreF by:

• Evaluating the population impact in terms of 

• annual resource utilization 

• total cases

• total costs 

• deaths

• quality-adjusted life-years (QALYs)

• Comparing the incremental cost-effectiveness ratio (ICER) of RSVpreF to natural history/no 

vaccine.

• Running scenario analyses outcomes that explore key areas of uncertainty.

• Perspective: Societal

51
Methods: Intervention(s)

• Target population: US pregnant persons

• Interventions:

1. No vaccination (Natural history)

2. RSVpreF against RSV illness

• Timeframe: 1 year (1 RSV season)

• Analytic horizon: infant’s lifetime

• Discount rate: 3%

52
Methods: Decision tree model

53

Natural

History

RSVpreF

Infection 

Hospitalization

ED

None of the above

Outpatient

Alive

Dead

Infection

Adverse 

Events

Prematurity

Injection site reaction

None of the above

Serious adverse event Infection 

Infection
Methods: Epidemiology

Hospitalization

54

Base Case Range Source

Respiratory syncytial virus (RSV) 

incidence, per 100,000 See Above See Above CDC NVSN, 

December 2016 to September 2020

Proportion with LRTI

Age 0-5 months 1.0 0.5-1.0 Rainisch, 2020

Age 6-11 months 1.0 0.5-1.0 Rainisch, 2020

CDC New Vaccine Surveillance Network (NVSN) hospitalization rates for children under 2 years of age from December 2016 to September 2020

 -

 1,000

 2,000

 3,000

 4,000

0 2 4 6 8 10 12 14 16 18 20 22

Hospitalization rate 

per 100,000 

children

Age in months
Methods: Epidemiology

ED and Outpatient

55

Respiratory syncytial virus (RSV) 

incidence, per 100,000 

Base Case Range Source

Emergency Department

Age 0-5 months 7,500 5,500 – 7,500 Lively 2019 (base case and range), Hall 

2009 (range)

Age 6-11 months 5,800 5,700 – 5,800 Lively 2019 (base case and range), Hall 

2009 (range)

Age 12-23 months 3,200 3,200 – 5,300 Hall 2009 (base case and range), Lively 

2019 (range)

Proportion with LRTI

Age 0-5 months 0.65 0.25-1.0 Rainisch, 2020

Age 6-11 months 0.5 0.25-1.0 Rainisch, 2020

Outpatient

Age 0-5 months 21,600 13,200 – 21,600 Lively 2019 (base case and range), Hall 

2009 (range)

Age 6-11 months

24,600

17,700 – 24,600 Lively 2019 (base case and range), Hall 

2009 (range)

Age 12-23 months 18,440 6,600 – 29,620 Jackson 2021 (base case and range), 

Hall 2009 (range)

Proportion with LRTI

Age 0-5 months 0.65 0.25-1.0 Rainisch, 2020

Age 6-11 months 0.3 0.1-1.0 Rainisch, 2020

LRTI= Lower respiratory tract infection
Methods: Epidemiology

Mortality

56

Base 

Case

Range Source

RSV mortality per 

hospitalization

Age 0-5 months 0.10%

0.04-0.20% Hansen 2022, 

Doucette 2016

Age 6-11 months 0.10%

0.04-0.20% Hansen 2022, 

Doucette 2016

Age 12-23 months 0.3% 0.28%-0.34% Gupta 2016
Seasonality

57

0%

5%

10%

15%

20%

25%

30%

Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Fraction of Annual Infections

Source: National Respiratory and Enteric Virus Surveillance System (NREVSS) (2015-2019)
Methods: Efficacy

58

Variable Base case 

value

Range for 

sensitivity 

analysis

Source

RSVpreF

Initial efficacy (months 0-5) 

against medically-attended 

RSV-associated LRTI 51.3% 29.4% - 66.8%

Kampmann

et al, 2023

Initial efficacy (months 0-5) 

against hospitalized RSVassociated LRTI 56.8% 10.1% - 80.7%

Kampmann

et al, 2023

Efficacy months 6-12 0

Assumed 0% efficacy against upper respiratory tract infections

LRTI= Lower respiratory tract infection
Methods: Medical Costs

Variable Value Range Source

Disease-specific 

hospitalization costs (per 

hospitalization) 

Age 0-11 months $11,487 4,804 - 86,646

Bowser 2022

Age 12- 23 months $11,469 4,804 - 86,646

Disease-specific ED costs 

(per ED visit) $563 544 - 581 Bowser 2022

Disease-specific 

outpatient costs (per 

outpatient visit)

$82 46 - 118 Bowser 2022

59

• Bowser, 2022 is a systematic review using studies from 2014-2021

• Funded by Sanofi

• All numbers updated to 2022 dollars using GDP Deflator
Methods: Productivity costs

Variable Value Range Source

Productivity burden of RSV 

disease (caregiver losses)

Days of lost productivity

Outpatient* 2.5 0-5

Fragaszy, 2018; Petrie, 2016; 

Van Wormer, 2017

ED* 2.5 0-5

Fragaszy, 2018; Petrie, 2016; 

Van Wormer, 2017

Hospitalization^ 7.4 0-14

Lifetime productivity for 

those <1 year old (lost from 

death)

1,795,936 1,346,951-

2,244,919

Grosse, 2019

60

*Productivity for outpatient and ED based on adult influenza

^Hospitalization productivity loss = length of hospitalization + 2 days
Methods: Intervention cost

Variable Value Range Source

Immunization-related costs

RSVpreF, per dose $295 50 – 500

Assumption: Manufacturer 

costs for adult vaccine

RSVpreF administration $16.96 15 - 22 Medicare: HCPCS 90460

61

Both assume no additional visits, but do include costs of administration
Methods: Adverse event costs

Variable Value Range Source

RSVpreF Maternal Adverse 

Events

Rate of injection site reaction 0.41 0.38 – 0.44 Pfizer Phase 3 Trial

Probability of healthcare 

visit, given injection site 

reaction

0.02 0.015 – 0.025 Curran, 2020

Cost of outpatient visit $367.76 23.15 – 1,758 (Deluca, 2023)

Recipient time, physician 

office for injection site 

reaction (hours)

2 1 - 3 Assumption 

Hypothetical serious 

adverse event 0.000001 0 - 0.0002

Base: Prosser, 2006

High: 95% CI Phase 3 data for 

RSV adult vaccines

62
63

Kampmann B, Madhi SA, Munjal I, Simões EA, Pahud BA, Llapur C, Baker J, Pérez Marc G, Radley D, Shittu E, Glanternik J. 

Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. New England Journal of Medicine. 2023 Apr 5.

Methods: Prematurity?

1% Difference?
Methods: Prematurity scenario

Variable Value Range Source

RSVpreF infant adverse 

events

Higher Rate of Prematurity 0% 0-2% Pfizer Phase 3 Trial

* All costs updated to 2022 using GDP Deflator 64

Outcomes, per prematurity

Lifetime cost of late 

prematurity

Medical $ 23,241 $11,621 –

$46,482 Waitzman, Jalali, Grosse, 2021

Productivity $ 11,447 $5,724 –

$22,894 Waitzman, Jalali, Grosse, 2021

QALYs lost from late 

prematurity 0.03 0 – 1.2

Werner, Hauspurg, Rouse, 2015

Petrini et al, 2008, Hirvonen et al, 2014, Crump 

et al, 2021, Darcy-Mahoney et al, 2016, Carroll 

et al, 2009, Payakachat et al, 2014
Methods: RSV 

health-related quality of life

65

LRTI quality-adjusted life DAYS lost Base Lower (Regnier) Upper (JIVE)

Outpatient: Child 3.1 1.8 16.6

Outpatient: Caregiver 1.5 0 9.1

ED: Child 4.9 2.9 16.6

ED: Caregiver 2.5 0 9.1

Hospitalized: Child 6.2 3.7 26.5

Hospitalized: Caregiver 2.4 0 13.6

Measured in 

Days Lost

Most 

Likely
Methods: Epidemiological model

Seasonality

Incidence

• Outpatient

• ED

• Hospitalizations

Nirsevimab

Waning 

Protection

Health Effects

• Outpatient

• ED

• Hospitalizations

• Deaths

Economic Effects

• Intervention

• Disease

• Societal

• QALYs

• ICER

Interventions

Epidemiology

Timing

Cost Burden/

• Outpatient

• ED

• Hospitalizations

Health Economics

Health Burden/

• Outpatient

• ED

• Hospitalizations

66
Methods: Inputs

• Incidence

• Raw reported incidence may be underreported because of imperfect PCR 

sensitivity, so we consider an additional scenario in sensitivity analysis:

• based on CDC Unpublished re-analysis of raw data from Zhang et al study which found 

decreased RSV PCR sensitivity in light of paired serology testing (adjustment factor: 

87.6%).

67
Health-Related Quality-of-Life

• Sources

• Glaser (2022)

• Estimate based on comparison of utility losses between premature children who had RSV vs. 

premature children without RSV and their caregivers

• Used as base case for hospitalization for children and their caregivers

• Regnier (2013) 

• Estimate QALY losses for hospitalization, ED visits, and outpatient visits for children with 

pertussis 

• Use relative QALYs between hospitalization, ED, and outpatient to estimate base losses for ED 

and outpatient in base case

• JIVE RSV Utilities Survey (2021)

• Estimates QALY losses for hospitalization and outpatient visits for child and caregiver

• Estimates may be impacted by COVID-related concerns about respiratory viruses

• Inform upper bound of range

68
69

Timing of those who received vaccination during pregnancy

RSVpreF is assumed to start earlier at week 24 (vs. week 27)

Methods: Provision of RSVpreF

0

0.05

0.1

0.15

0.2

0.25

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Fraction Vaccinated (given receipt 

of vaccine)

Gestational Age

Reported Tdap Modeled RSVpreF vaccination timing
70

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

0 10 20 30 40 50

Gestational Age (Week)

Source: NCHS from 2019 and 2021

Methods: Birth Timing
Validation

231

66

8

225 

65 

13 

0

50

100

150

200

250

Outpatient Clinic

Visits

Rates of Medically

ED Visits Hospitalizations

-Attended RSV 

(per 1000 births)

Rainisch et al, Vaccine, 2020 JIVE model

71
Methods: Maternal Adverse Event Health Effects

Variable Value Range Source

Adult Quality-Adjusted LifeYears lost due to adverse events

Injection Site Reaction 0 Assumed

Serious Adverse Event 0.141 0.092-0.199 Prosser, 2006

72
Results: Health outcomes

73

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group

URTI= upper respiratory tract infection; LRTI= lower respiratory tract infection

 -

 100,000

 200,000

 300,000

 400,000

 500,000

 600,000

 700,000

 800,000

 900,000

Natural

History

RSVpreF Natural

History

RSVpreF Natural

History

RSVpreF

Outpatient Emergency Department Inpatient

Number of Events in Cohort

URTI LRTI
Results: Events Averted

74

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group

45,693

15,866

7,571

1,666

40,884

4,997

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Events Averted per Year

RSVPreF
Results: QALYs Lost

75

Adverse 

Events Outpatient ED Inpatient Deaths Total Grand

Child Caregiver Child Caregiver Child Caregiver Child Child Caregiver Total

Natural 

History 7,153 3,580 3,290 1,645 807 320 1,356 12,606 5,545 18,151 

RSVpreF 0.2495 6,766 3,387 3,075 1,538 679 269 1,141 11,663 5,194 16,857 

Cohort: 3.66 million births, assuming 50% intended uptake in RSVpreF group

QALY= quality-adjusted life-year
76

Sensitivity: Hospitalization Mortality

Base

$0

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

$350,000

$400,000

$450,000

$500,000

0.00% 0.20% 0.40% 0.60% 0.80% 1.00% 1.20%

ICER

Hospitalized Mortality
Scenario: Prematurity

77

Base Case

 $-

 $200,000

 $400,000

 $600,000

 $800,000

 $1,000,000

 $1,200,000

 $1,400,000

 $1,600,000

0.0% 0.5% 1.0% 1.5% 2.0%

ICER

Excess Prematurity
Scenario: Upper Respiratory Tract Infection Effect

78

RSVpreF is assumed to have 37.9% efficacy for upper respiratory tract infections based on overall respiratory tract 

efficacy from phase 3 trial (Kampmann, 2023)

ICER= incremental cost effectiveness ratio; QALY= Quality adjusted life year

$279,490/QALY

 $-

 $100,000

 $200,000

 $300,000

 $400,000

 $500,000

 $600,000

$0 $50 $100 $150 $200 $250 $300 $350 $400 $450 $500

ICER

Total Cost of RSVpreF
Appendix to Economics of combined use of Pfizer 

maternal RSVpreF vaccine and nirsevimab

79
Methods: Study questions

• Determine the cost-effectiveness of:

• Nirsevimab in children born to mothers who received RSVpreF at least 2 weeks prior to 

delivery

• RSVpreF for pregnant persons who will give nirsevimab to their newborns

• Single individual

• Evaluate by month of year

• Perspective: Societal

• Timeframe: 1 year (1 RSV season)

• Analytic horizon: infant’s lifetime

• Discount rate: 3%

80
81

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Fraction of Annual Infections

Source: National Respiratory and Enteric Virus Surveillance System (NREVSS) (2015-2019)

Reminder: Seasonality
Methods: Intervention effectiveness

82

* Assuming administration of nirsevimab at birth

0%

20%

40%

60%

80%

100%

0 2 4 6 8 10 12 14

Hospitalization Efficacy

Months since birth

RSVPreF Both Nirsevimab
0%

20%

40%

60%

80%

100%

0 2 4 6 8 10 12 14

Hospitalization Efficacy

Months since birth

RSVPreF Both Nirsevimab

Methods: Intervention effectiveness

83

Additional benefit of adding RSVpreF

* Assuming administration of nirsevimab at birth
0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 2 4 6 8 10 12

Hospitalization Efficacy

Month

Both Nirsevimab Only

Methods: Intervention effectiveness

example: Off-peak (Aug) birth

Additional benefit of adding RSVpreF

84
Results: Adding nirsevimab to all infants born to 

vaccinated mothers

0.0000

0.0500

0.1000

0.1500

0.2000

0.2500

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Additional Events Averted Per 

Infant Given Nirsevimab

1x 2x 3x 6x 10x

85

Nirsevimab given at birth for infants born October-March, and in October/November for infants born in April through 

September
Results: Adding nirsevimab at the start of the 

season only for infants born Apr-Sept

0.0000

0.0500

0.1000

0.1500

0.2000

0.2500

0.3000

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Additional Events Averted Per 

Infant Given Nirsevimab

1x 2x 3x 6x 10x

86

Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF
Results: Adding nirsevimab during the season for 

infants born Oct-Mar

0.0000

0.0500

0.1000

0.1500

0.2000

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Additional Events Averted Per 

Infant Given Nirsevimab

1x 2x 3x 6x 10x

87

Nirsevimab given in October/November for babies born in April through September born to mothers who received 

RSVpreF